FOR THE DISTRICT OF ARIZONA
FLAGSTAFF DIVISION
COMES NOW the Plaintiffs, Elaine Shubin and Patrick Shubin
(“Plaintiffs”), by and through their undersigned attorneys, and
files this their
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mailto:
[email protected]
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Complaint for damages against Defendants, Wright Medical
Technology, Inc., a
Delaware corporation; Wright Medical Group, Inc., a Delaware
corporation; and
MicroPort Orthopedics, Inc., a Delaware corporation, and allege the
following
causes of action against Defendants, and each of them, as
follows:
NATURE OF THE ACTION
1. Defendants have long known that their device design has an
unacceptable tendency to fret and corrode at the location of the
modular neck-
stem-body junction during even low to moderate physical activity.
Defendants
have known for years that their hip replacement device – the
PROFEMUR ® Total
Hip System with PROFEMUR ® Stem (“Stem”) and PROFEMUR
® Modular
Neck (“Modular Neck”) (collectively “the PROFEMUR ® Total Hip
System” or
“the Device” – was prone to fail within a few years of implantation
causing severe
debilitating tissue destruction. Significantly, consequent to
reports of fretting-
corrosion and fracture at the Stem and Modular Neck junction,
Defendant
MicroPort issued a recall and ceased marketing the Device. As a
result of the
Device’s defects and Defendants’ tortious acts/omissions, Plaintiff
Elaine Shubin,
and many other patients who received these devices, endured
unnecessary pain and
suffering; debilitating lack of mobility; and a subsequent more
difficult revision
surgery to replace the defective Device, giving rise to more pain
and suffering,
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prolonged recovery time, and increased risk of complications and
death from
surgery.
2. This is an action for strict products liability, negligence,
breach of
express and implied warranties, fraudulent misrepresentation,
fraudulent
concealment, negligent misrepresentation, loss of consortium, and
punitive
damages brought by Plaintiffs Elaine Shubin and Patrick Shubin for
injuries arising
out of the failure of the PROFEMUR ® Total Hip System, Plaintiff
Elaine Shubin
received as part of her total hip replacement surgery.
PARTIES
3. Plaintiffs Elaine Shubin and Patrick Shubin at all times
relevant hereto
were residents of Flagstaff, Coconino County, State of Arizona.
Plaintiff Elaine
Shubin underwent a left total hip arthroplasty surgery performed by
Michelle
Ward, M.D. at San Antonio Regional Hospital on October 30, 2015. At
that time,
the PROFEMUR ® Total Hip System manufactured, designed,
distributed, labeled,
marketed, and warranted by Defendants was implanted into Plaintiff
Elaine
Shubin. Plaintiff Elaine Shubin’s surgeon, medical staff, and other
healthcare
providers met or exceeded the standard of care applicable to the
hip replacement
surgery. The PROFEMUR ® Total Hip System implanted on Plaintiff’s
left side
subsequently failed, and necessitated revision surgery. At the time
of Plaintiff’s
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promoted and distributed the PROFEMUR ® Total Hip System.
4. Defendant Wright Medical Technology, Inc. (“WMT”) is a
corporation organized under the laws of the State of Delaware, with
its principal
place of business located in Memphis, Tennessee, and as such is a
citizen of both
the State of Tennessee and the State of Delaware. Defendant WMT is
registered to
do business in the State of Arizona and may be served with process
by serving its
registered agent for service, Corporation Service Company, at 2338
W. Royal
Palm Road, Suite J, Phoenix, Arizona 85021. At all times relevant
hereto,
Defendant WMT conducted regular and sustained business in the State
of Arizona
by selling and distributing its products in Arizona and engaged in
substantial
commerce and business activity in the County of Coconino.
5. Defendant Wright Medical Group, Inc. (“WMG”) is a
corporation
organized under the laws of the State of Delaware, with its
principal place of
business located in Memphis, Tennessee, and as such is a citizen of
both the State
of Tennessee and the State of Delaware. Defendant WMG may be served
with
process by serving its registered agent for service, Corporation
Service Company,
at 2908 Poston Avenue, Nashville, Tennessee 37203-1312. At all
times relevant
hereto, Defendant WMG conducted regular and sustained business in
the State of
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Arizona by selling and distributing its products in Arizona and
engaged in
substantial commerce and business activity in the County of
Coconino.
6. Defendant MicroPort Orthopedics, Inc. (“MicroPort”) is a
corporation
organized under the laws of the State of Delaware, with its
headquarters and
principal place of business located in Arlington, Tennessee, and as
such is a citizen
of the State of Tennessee and the State of Delaware. Defendant
MicroPort is
registered to do business in the State of Arizona and may be served
with process by
serving its registered agent for service, the CT Corporation
System, at 3800 N.
Central Avenue, Suite 460, Phoenix Arizona 85012. At all times
relevant hereto,
Defendant MicroPort conducted regular and substantial business in
the State of
Arizona by selling and distributing its products in Arizona, and
engaged in
substantial commerce and business activity in the County of
Coconino.
FACTUAL ALLEGATIONS
8. In December 1999, WMT and WMG (collectively “Wright”)
acquired
Cremascoli, its product lines, documents, and manufacturing
facilities, including
the Profemur ® line of hip products.
9. After the acquisition of Cremascoli, Wright re-designed
the
Profemur ® modular artificial hip stem and modular neck, expanded
the product line
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to include additional titanium models or versions of Profemur ®
stems and
Profemur ® modular necks, and rebranded the Cremascoli titanium
modular neck
product line, and compatible titanium artificial hip stems, as the
Wright Profemur ®
Total Hip System.
10. By way of what is known as Section 510(k) premarket
notification
process, on December 13, 2000, Wright received clearance from the
U.S. Food and
Drug Administration (FDA) to distribute in the United States its
first titanium
modular neck and stem artificial hips.
11. The FDA never approved the safety or effectiveness of
Wright’s
newly rebranded hip implant system and product line of modular
necks, but instead
merely accepted Wright’s assertion that the Profemur® Hip System
was
substantially equivalent to an already legally marketed device
(i.e., the Cremascoli
modular neck component acquired by Wright in December 1999).
12. The 510(k)-clearance process is distinct from the FDA
pre-market
approval (PMA) process in that clearance does not require clinical
confirmation of
safety and effectiveness and as such the manufacturer retains all
liability for the
assertions of safety and effectiveness.
13. Sometime after December 13, 2000, Wright began to
manufacture,
label, market, promote, distribute and sell in the United States
the hip implant
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devices branded as “Profemur ® Total Hip System” under the 510(k)
clearance,
which included titanium stems and titanium modular necks.
14. The Wright Medical Profemur ®
modular necks that were distributed
by Wright after December 13, 2000, and before August 25, 2009, were
all made of
the titanium-aluminum-vanadium alloy known as Ti6Al4V.
15. In the year 2000 and in all years thereafter to the present,
Ti6Al4V
was an alloy generally available for use in manufacturing
implantable medical
devices.
16. In the year 2000 and in all years thereafter to the present,
monoblock
hip implant stems without modular neck-stem junctions were readily
available in
the market.
17. In various marketing and promotional material published
and
distributed by Wright from approximately the year 2002, and into
the year 2005,
and available to Wright’s sales representatives and distributors,
surgeons, patients
and the general public, Wright made the following representations,
statements,
claims and guarantees about its Profemur ® modular necks:
The modular neck used with the Profemur ® hip has been employed
by
Wright Cremascoli for over fifteen years. The necks were designed
in 1985
and have been successfully implanted in over 50,000 patients
requiring both
primary and revision hip procedures. The necks are used in other
Wright
Cremascoli hip systems besides the Profemur ® hip. None of the
necks has
experienced a clinical failure since their inception [emphasis
added].
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and
The modular neck system, designed by Cremascoli in 1985 (U.S.
Patent No.
4,957,510), has now been successfully implanted in over 50,000
patients
requiring both primary and revision hip arthroplasty. Extensive
laboratory
tests have proven that the coupling between the modular neck and
femoral
implant guarantees:
Structural reliability
[Wright Medical Technology Monograph MH688-102 © 2004].
18. On or about April 19, 2005, Wright first reported to the FDA
a
Profemur ® modular neck clinical failure where a Ti6Al4V modular
neck implanted
in a patient experienced a catastrophic fracture (i.e., breaking
into two pieces) due
to fretting and corrosion at the oblong tapered distal end where
the neck is seated
in the stem.
19. After receiving notice of the first modular neck fracture,
Wright
received notice of additional modular neck clinical failures from
corrosion based
fractures of the modular necks.
20. The number of Profemur ® Ti6Al4V modular neck clinical
corrosion
based fractures has continued to increase over time, and continues
to increase to
the present day, now numbering more than 800 such clinical
failures.
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21. As the number of reported Wright Ti6Al4V modular neck
fractures
continued to increase and the FDA became aware of its dismal
clinical
performance, case studies appeared in medical journals reporting
the fracture of
Wright titanium Profemur ® modular necks and identifying
micromotion and
fretting corrosion at the neck-stem junction as the cause and mode
of failure.
22. At some point in time prior to August 25, 2009, Wright had
notice
that a higher than normal rate of early failure of its Profemur ®
line of hip implant
devices were failing by fracture at the modular neck junction
secondary to
micromotion, fretting and corrosion.
23. As the number of reported Wright Ti6Al4V Profemur ® modular
neck
fractures continued to increase, Wright, rather than redesigning
its hip implant
system to eliminate the modular neck-stem junction and thereby
eliminate
micromotion and fretting-corrosion, instead began to design and
develop a
Profemur ® modular neck made of a cobalt chrome (CoCr) metal alloy
utilizing the
same taper design as the titanium modular necks and the same
Profemur ® stems.
24. On April 16, 2009, Wright submitted a Section 510(k)
premarket
notification of intent to market a device generally identified as
Profemur ® hip
system modular necks made of a cobalt chrome alloy to the FDA to be
coupled
with existing Profemur ® stems.
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25. On or about August 25, 2009, Wright began to market and offer
for
distribution and sale in the United States Profemur ® modular Necks
made of cobalt
chromium alloy, and Wright simultaneously began withdrawing from
the market
its Profemur ® modular necks comprised of Ti6Al4V titanium
alloy.
26. Wright could have eliminated the potential for fretting and
corrosion
at the modular neck junction of its Profemur ® hip implants by
redesigning and/or
abandoning modularity and manufacturing, designing, and marketing
monoblock
stems, but it chose not to do so because Wright did not want to
lose its investment
in the market share for the use of its modular stems in primary hip
implant
arthroplasties.
27. In promoting its Profemur ® CoCr modular Necks, Wright claimed
that
the cobalt chrome modular Necks would result in less fretting than
occurred with
Ti6Al4V modular necks.
28. The design of the Profemur ® CoCr modular Neck, when coupled
with
the design of the titanium Profemur ® hip Stems, is such that it in
fact promotes the
process of fretting corrosion of more harmful metal particles at
the modular Neck-
Stem junction.
29. The Profemur ® CoCr modular Necks that Wright designed
and
manufactured were designed to be used with most, if not all, of the
same femoral
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heads and most, if not all, of the same Profemur ® titanium hip
Stems as were its
titanium (Ti6Al4V) Profemur ® modular necks.
30. While promoting its Profemur ® CoCr modular Necks Wright
Medical
stated, “[p]roduct complaint data reported to Wright to date does
not indicate an
increased risk, as compared to traditional titanium necks, of
adverse events due to
taper junction fretting and corrosion or fractures for Profemur ®
CoCr modular
Necks.” [See Profemur ® CoCr Modular Necks Frequently Asked
Questions,
Wright Medical publication MH 1619-812.]
31. Wright’s statement in its promotional materials that
“[p]roduct
complaint data reported to Wright to date does not indicate an
increased risk, as
compared to traditional titanium necks, of adverse events due to
taper junction
fretting and corrosion or fractures for Profemur ® CoCr modular
Necks,” was not
supported by unbiased sound scientific testing.
32. The claim by Wright that “[p]roduct complaint data reported
to
Wright to date does not indicate an increased risk, as compared to
traditional
titanium necks, of adverse events due to taper junction fretting
and corrosion or
fractures for Profemur ® CoCr modular Necks” was false and/or
misleading.
33. While promoting its Profemur ®
CoCr modular Necks, Wright claimed
that its CoCr modular Necks would result in less fretting than
occurred with
titanium modular necks.
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34. Claims by Wright that its CoCr modular Necks would result in
less
fretting than occurred with titanium (Ti6Al4V) modular necks were
not supported
by unbiased, sound scientific testing.
35. Claims by Wright that its CoCr modular Necks would result in
less
fretting than occurred with titanium (Ti6Al4V) modular necks were
false and/or
misleading.
the design of the titanium (Ti6Al4V) Profemur ®
hip Stems, is such that it in fact
encourages the process of fretting corrosion at the modular
Neck-Stem junction.
37. Prior to offering its Profemur ® CoCr modular Necks for
distribution
or sale in the United States, Wright nor MicroPort adequately
tested the design of
CoCr Profemur ® modular Necks for fretting corrosion or the
biological effects of
cobalt and chromium corrosion, metal debris and metal ions on the
body of
patients.
38. Prior to offering its Profemur ® CoCr modular Necks for
distribution
or sale in the United States, Wright nor MicroPort adequately
tested the design of
the CoCr Profemur ® modular Necks for corrosion or the biological
effect of
corrosion on the body after implantation in patients.
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39. Wright rushed the Profemur ® CoCr modular Necks to market
without
adequately testing it for in vivo performance, including, but not
limited to,
resistance to fretting and corrosion or the effects of corrosion on
human tissue.
40. Wright rushed the Profemur ® CoCr modular Necks to market in
order
to preserve market share and its profits from the sale of its
failing Profemur ® hip
implant products.
41. Years before Plaintiff Elaine Shubin was implanted with the
Device,
Wright had been informed that the Profemur ® CoCr modular Necks
were corroding
in patients to the extent that revision surgeries were necessary to
remove the
Profemur ® CoCr modular Necks.
42. In January of 2014, Wright sold the OrthoRecon Division,
Wright’s
operating unit for the manufacture and sale of Wright’s hip and
knee implants, to
MicroPort.
43. MicroPort and Wright knew or should have known that as of
October
30, 2015, the date Plaintiff Elaine Shubin received her Wright
Profemur ® Total
Hip System that:
(a) Wright and MicroPort had not adequately tested the Profemur
®
CoCr modular Necks to simulate in vivo performance for resistance
to
fretting-corrosion;
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Total Hip
(c) Wright and MicroPort had not adequately tested the Profemur
®
CoCr modular Necks to simulate in vivo performance for resistance
to
corrosion;
fretting-corrosion;
(e) There was an increased risk of fretting-corrosion at the
Neck-
Stem junction;
(f) There was an increased risk of corrosion at the Neck-Stem
junction;
and
(g) There was a substantial risk that patients’ bodies would
be
adversely affected by the exposure to corrosion, metal debris and
metal ions
secondary to cobalt and chromium fretting and corrosion.
44. The Neck-Stem junctions of the Profemur ®
CoCr modular Neck,
coupled with a Profemur ® titanium hip stem, are subject to
significant movement
which results in fretting-corrosion, pitting corrosion, metal
debris cast off and
metal ion release.
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45. Product complaint data reported to Wright and MicroPort prior
to
October 30, 2015 indicated an increased risk of adverse events due
to tissue
exposure to metal debris and ion cast off from taper junction
fretting and corrosion
of the Profemur ® CoCr modular Necks when coupled with
Profemur
® titanium hip
Stems, as compared to traditional titanium necks or monoblock
stems.
46. Product complaint data reported to Wright and MicroPort prior
to
October 30, 2015 indicated an increased risk of adverse events due
to corrosion, as
compared to traditional monoblock stems or titanium necks when
coupled with the
Profemur ® hip stems.
47. Based upon what Wright and MicroPort knew or should have
known
before October 30, 2015, Wright and MicroPort should have informed
orthopedic
surgeons using the Profemur ® Total Hip Systems that there was an
increased risk
of fretting and corrosion for Profemur ® CoCr modular Necks when
coupled with
Profemur ® titanium hip stems.
® titanium modular
Stem and the Profemur ® Total Hip System are defective and
unreasonably
dangerous because of their design defects in that the harmful
characteristics or
consequences inherent in the product’s use for hip replacement,
when weighed
against the utility or benefit derived from the product, outweigh
the benefits which
might have been gained by placing the said defective devices
product in the body
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of Plaintiff Elaine Shubin. Further, the said devices were
defective and
unreasonably dangerous in that they failed to perform as safely as
an ordinary
consumer would expect when they were used in a reasonably
foreseeable manner.
49. Additionally, the Profemur ® CoCr modular Neck, Profemur
® titanium
modular Stem and the Profemur ® Total Hip System implanted in
Plaintiff Elaine
Shubin were defective in manufacture, as Wright manufactured same
such that the
tolerances between the Stem and Neck components did not comply with
Wright’s
design specifications.
50. Based upon the facts and allegations set forth above, the
Profemur ®
CoCr modular Neck, Profemur ® titanium Stem, and the Profemur
® Total Hip
System are defective and unreasonably dangerous in labeling in that
they do not
provide adequate warnings of the dangers or information of said
risks when the
device is used in a reasonably foreseeable manner.
51. Based upon the facts and allegations set forth above, the
Profemur ®
CoCr modular Necks, Profemur ® titanium modular Stem, and the
Profemur
® Total
Hip System are defective and unreasonably dangerous in that the
risks that were
inherent in the product being used for hip replacement, when
weighed against the
alleged utility or benefit derived from the product’s use, outweigh
the benefit.
52. Defendants WMT, WMG, and MicroPort were negligent and /
or
strictly liable in design, manufacture, distribution, sale,
marketing, promotion, and
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® titanium modular Stem,
and the Profemur ® Total Hip System.
53. Defendants were negligent and / or strictly liable in the
failure to warn
patients and/or surgeons that it had received product complaint
data that indicated
an increased risk of adverse events due to taper junction fretting
and cobalt
chromium corrosion, as compared to other available safe alternative
devices.
54. Defendants were negligent and / or strictly liable in failing
to warn
patients and surgeons that they had received product complaint data
that indicated
an increased risk of adverse events due to corrosion, as compared
to other available
safe alternative devices.
PLAINTIFF ELAINE SHUBIN’S PROFEMUR ® HIP
55. On or about October 30, 2015, Plaintiff Elaine Shubin had
a
Profemur ® Total Hip System implanted in her left hip (“Index
Surgery”) in a
procedure known as a total hip arthroplasty (or “THA”).
56. Orthopedic surgeon Michelle Ward, M.D. (“Dr. Ward”) performed
the
Index Surgery during which she implanted the Profemur ® Total Hip
System in
Plaintiff Elaine Shubin.
57. Plaintiff Elaine Shubin’s Index Surgery was performed at
San
Antonio Regional Hospital in Upland, California.
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58. Dr. Ward did not breach any generally accepted standard of care
in
the field of orthopedic surgery in her care and treatment of
Plaintiff Elaine Shubin
or negligently cause any injury to Plaintiff in any of the
following respects:
(a) In the care or treatment that she provided to Plaintiff
Elaine
Shubin prior to beginning the hip implant surgery;
(b) In the hip implant surgery, she performed on Plaintiff
Elaine
Shubin;
or
(c) In the care or treatment that she provided to Plaintiff
Elaine
Shubin subsequent to Plaintiff’s hip implant surgery.
59. Based upon the patient population that Wright and MicroPort
intended
the Device to be implanted in, at the time of Plaintiff Elaine
Shubin’s Index
Surgery, she was an appropriate patient to be implanted with the
Profemur ® Total
Hip System.
60. Dr. Ward recommended the Profemur Total Hip System to
Plaintiff
Elaine Shubin and indicated that the Device was appropriate for
her.
61. Plaintiff Elaine Shubin reasonably relied upon Dr. Ward in
deciding
to proceed with hip replacement surgery and have the Profemur
®
Total Hip System
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62. Before or during the course of Plaintiff Elaine Shubin’s
Index
Surgery, Defendants MicroPort and/or Wright arranged for the
Profemur ®
Total
Hip System that was implanted in Plaintiff to be delivered to San
Antonio Regional
Hospital and/or Dr. Ward for implantation in Plaintiff Elaine
Shubin.
63. Defendants, directly or through their subsidiaries or
affiliates,
designed, manufactured, distributed, marketed, delivered and sold
in the United
States various prosthetic orthopedic devices, including the
Profemur ®
Total Hip
System implanted in Plaintiff Elaine Shubin during the Index
Surgery.
64. At the Index Surgery, each of the components of Plaintiff
Elaine
Shubin’s Profemur ® Total Hip System was in substantially the same
condition in
all relevant respects as when they left Defendants’ control.
65. At all times relevant hereto, Plaintiff Elaine Shubin used
the
Profemur ® Total Hip System implanted during the Index Surgery in a
normal and
reasonably foreseeable manner.
66. On or about March 9, 2020, Plaintiff Elaine Shubin reported to
Dr.
Amber Randall (“Dr. Randall”) for revision surgery of her failed
hip prosthesis
(“Revision Surgery”). Dr. Randall recommended the revision surgery
after
Plaintiff Elaine Shubin presented with elevated cobalt ion level,
severe pain, and
lack of mobility.
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67. Plaintiff Elaine Shubin’s Revision Surgery was necessary
because the
Device failed due to corrosion at the Neck-Stem junction of the
Device.
68. But for the fact that the CoCr modular Neck of Plaintiff
Elaine
Shubin’s Device had corroded causing it to fail and injure
Plaintiff, Plaintiff’s
Device was not otherwise in need of revision.
69. On or about March 9, 2020, it was discovered that the Device
failed
due to corrosion of the oblong taper of the Profemur ® CoCr modular
Neck where it
seated in the pocket of the Profemur ® titanium Stem, which caused
continuing and
otherwise irreversible physical injury to Plaintiff Elaine
Shubin.
70. On or about March 9, 2020, the Profemur ® Total Hip
System
implanted in Plaintiff Elaine Shubin’s left hip was discovered to
have failed as a
direct and proximate result of the actions, conduct, negligence,
and breach of
duties of the Defendants, as alleged in this Complaint.
71. The Profemur ® Total Hip System (and its components), to
include the
Device implanted in Plaintiff Elaine Shubin was not merchantable,
but was
defective and unreasonably dangerous for its intended and/or
reasonably
foreseeable uses in that:
(a) it was and is defective and unreasonably dangerous under
Arizona’s product
liability law as a result of one or more or a combination of the
following:
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(i) the Neck was manufactured/designed in such a manner as to be
subjected to
excessive micromotion and fretting corrosion, thereby increasing
the potential for
failure;
(ii) the Neck was manufactured/designed in such a manner as to be
subjected to
excessive micromotion, fretting and corrosion, thereby increasing
the potential for
injury and failure;
(iii) the surface of the section of the Neck that was inserted into
the modular
Stem was manufactured/designed in such a manner as to increase the
potential for
fretting and corrosion, thereby increasing the potential for injury
and failure;
(iv) the portion of the Neck that was inserted into the modular
Stem was in a
narrow, confined space, thereby increasing the potential for
fretting, corrosion,
injury and failure;
(v) the components were manufactured/designed in such a way as to
make the
modular Neck component susceptible to micromotion, fretting and
corrosion,
thereby increasing the potential for injury and failure;
(vi) the components were manufactured/designed in such a way as to
cause
dissimilar metals (i.e., a CoCr modular Neck and titanium modular
Stem) to mate
by insertion into a narrow, confined space, thereby increasing the
potential for
corrosion; and
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(vii) there may be other conditions or defects yet to be
determined.
(b) it was also defective and unreasonably dangerous in that the
said devices
failed to perform as safely as an ordinary consumer would expect or
was dangerous
to an extent beyond which could be contemplated by the ordinary
consumer with
the ordinary knowledge common to the community as to its
characteristics in that:
(i) the ordinary consumer would not contemplate that the Device
would become
so corroded that premature revision surgery would become necessary
less than 5
years after implantation; and
(ii) the ordinary consumer would not contemplate that the ordinary
activities of
daily living would result in the Device releasing harmful metal
ions and metal
debris in the consumer’s body that caused adverse tissue reactions
and other
medical complications.
72. The Device was not tested in design and development under
conditions that were known would be encountered in the normal in
vivo patient
environment over reasonable periods of time.
73. The Device was not tested in design and development under
the
normal in vivo patient environmental conditions that were known
would be
encountered during normal use of the Device.
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74. The Device was not tested for the FDA Section 510(k)
Premarket
Notification Process under conditions that were known would be
encountered in
the normal in vivo patient environment.
75. The testing performed by Wright and MicroPort of the Device did
not
adhere to or meet FDA guidance.
76. The Device’s design was known by Defendants to be failing
from
fretting and corrosion of the modular Neck-Stem junction prior to
the day of its
FDA 510(k) Premarket Notification Application.
77. The Device was known by Defendants to be failing at higher
than
expected rates from micromotion, fretting and corrosion of the
modular Neck-Stem
junction prior to the date of its implantation in Plaintiff Elaine
Shubin during the
Index Surgery.
78. The Device’s design was known by Defendants to be failing at
higher
than expected rates due to fretting and corrosion prior to the date
of Plaintiff Elaine
Shubin’s Revision Surgery, during which the Device was discovered
to be
corroded at the Neck-Stem junction.
79. Prior to the Index Surgery, Defendants did not warn
patients,
surgeons, customers, or their sales representatives/distributors
that the Device was
known to be failing from corrosion at higher than expected
rates.
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80. On or about March 9, 2020, Plaintiff Elaine Shubin discovered
the
Device implanted in her left side failed due to corrosion as a
result of one or more
or a combination of the foregoing unreasonably dangerous
conditions.
81. As a direct and proximate result of the failure of the Profemur
® Total
Hip System, Plaintiff Elaine Shubin has sustained injuries and
damages, including,
but not limited to:
(a) undergoing surgery to remove and replace the failed prosthesis
and repair
the damage that failure caused;
(b) past and future pain, suffering, and anguish, both in mind and
in body;
(c) permanent diminishment of her ability to participate in and
enjoy the affairs
of life;
(d) medical bills associated with the revision surgery,
rehabilitation, and
recovery therefrom;
(g) permanent physical impairment.
(h) serious and permanent physical injuries to bone, muscle,
tendons, tissues and
nerves in her hip and pelvis;
(i) loss of earnings and any decrease in earning power or capacity
in the future.
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FEDERAL STATUTORY AND REGULATORY REQUIREMENTS
82. Pursuant to federal law, a medical device is deemed to be
adulterated
if, among other things, it fails to meet established performance
standards, or if the
methods, facilities or controls used for its manufacture, packing,
storage or
installation are not in conformity with federal requirements. 21
U.S.C. § 351.
83. Pursuant to federal law, a device is deemed to be misbranded
if,
among other things, its labeling is false or misleading in any
particular, or if it is
dangerous to health when used in the manner prescribed, recommended
or
suggested in the labeling thereof. 21 U.S.C. § 352.
84. Pursuant to federal law, manufacturers are required to comply
with
FDA regulation of medical devices, including FDA requirements for
records and
reports, in order to prohibit introduction of medical devices that
are adulterated or
misbranded, and to assure the safety and effectiveness of medical
devices. In
particular, manufacturers must keep records and make reports if any
medical
device may have caused or contributed to death or serious injury,
or if the device
has malfunctioned in a manner likely to cause or contribute to
death or serious
injury. Federal law also mandates that the FDA establish
regulations requiring a
manufacturer of a medical device to report promptly to FDA any
correction or
removal of a device undertaken to reduce a risk to health posed by
the device, or to
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remedy a violation of federal law by which a device may present a
risk to health.
21 U.S.C. § 360(i).
85. Pursuant to federal law, the Secretary of Health and Human
Services
may prescribe regulations requiring that the methods used in, and
the facilities and
controls used for, the manufacture, pre-production design
validation (including a
process to assess the performance of a device, but not including an
evaluation of
the safety or effectiveness of a device), packaging, storage and
installation of a
device conform to current good manufacturing practice, as
prescribed in such
regulations, to assure that the device will be safe and effective
and otherwise in
compliance with federal law.
86. The regulations requiring conformance to good
manufacturing
practices are set forth in 21 C.F.R. § 820, et seq. As explained in
the Federal
Register, because the Current Good Manufacturing Practice (CGMP)
regulations
must apply to a variety of medical devices, the regulations do not
prescribe the
details for how a manufacturer must produce a device. Rather, the
quality system
regulations provide a framework of basic requirements for each
manufacturer to
use in establishing a quality system appropriate to the devices
designed and
manufactured and the manufacturing processes employed.
Manufacturers must
adopt current and effective methods and procedures for each device
they design
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and manufacture to comply with and implement the basic requirements
set forth in
the quality system regulations.
87. Pursuant to 21 C.F.R. § 820.1(c), the failure to comply with
any
applicable provision in Part 820 renders a device adulterated under
section 501(h)
of the Federal Drug & Cosmetic Act (“the Act”). 21 U.S.C. §
351.
88. Pursuant to 21 C.F.R. § 820.5, each manufacturer shall
establish and
maintain a quality system that is appropriate for the specific
medical device
designed or manufactured. “Quality system” means the organizational
structure,
responsibilities, procedures, processes and resources for
implementing quality
management. 21 C.F.R. § 820.3(v).
89. Pursuant to 21 C.F.R. § 820.22, each manufacturer shall
establish
procedures for quality audits and conduct such audits to assure
that the quality
system is in compliance with the established quality system
requirements and to
determine the effectiveness of the quality system.
90. Pursuant to 21 C.F.R. § 820.30(a), each manufacturer shall
establish
and maintain procedures to control the design of the device in
order to ensure that
specified design requirements are met.
91. Pursuant to 21 C.F.R. § 820.30(d), each manufacturer shall
establish
and maintain procedures for defining and documenting design output
in terms that
allow an adequate evaluation of conformance to design input
requirements.
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92. Pursuant to 21 C.F.R. § 820.30(e), each manufacturer shall
establish
and maintain procedures to ensure that formal documented reviews of
the design
results are planned and conducted at appropriate stages of the
device’s design
development.
93. Pursuant to 21 C.F.R. § 820.30(f), each manufacturer shall
establish
and maintain procedures for verifying the device design to confirm
that the device
design output meets the design input requirements.
94. Pursuant to 21 C.F.R. § 820.30(g), each manufacturer shall
establish
and maintain procedures for validating the device design. Design
validation shall
be performed under defined operating conditions on initial
production units, lots or
batches, or their equivalents. Design validations shall ensure that
devices conform
to defined user needs and intended uses and shall include testing
of production
units under actual or simulated use conditions.
95. Pursuant to 21 C.F.R. § 820.30(h), each manufacturer shall
establish
and maintain procedures to ensure that the device design is
correctly translated into
production specifications.
96. Pursuant to 21 C.F.R. § 820.30(i), each manufacturer shall
establish
and maintain procedures for the identification, documentation,
validation or where
appropriate verification, review and approval of design changes
before their
implementation.
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97. Pursuant to 21 C.F.R. § 820.70(a), each manufacturer shall
develop,
conduct, control and monitor production processes to ensure that a
device
conforms to its specifications. Where deviations from device
specifications could
occur as a result of the manufacturing process, the manufacturer
shall establish and
maintain process control procedures that describe any process
controls necessary to
ensure conformance to specifications. Such process controls shall
include:
(a) documented instructions, standard operating procedures (SOPs)
and methods
that define and control the manner of production;
(b) monitoring and control of process parameters and component and
device
characteristics during production;
(d) the approval of processes and process equipment; and
(e) criteria for workmanship which shall be expressed in documented
standards
or by means of identified and approved representative
samples.
98. Pursuant to 21 C.F.R. § 820.70(b), each manufacturer shall
establish
and maintain procedures for changes to a specification, method,
process or
procedure.
99. Pursuant to 21 C.F.R. § 820.70(c), each manufacturer shall
establish
and maintain procedures to adequately control environmental
conditions that could
reasonably be expected to have an adverse effect on product
quality, including
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periodic inspection of environmental control system(s) to verify
that the system,
including necessary equipment, is adequate and functioning
properly.
100. Pursuant to 21 C.F.R. § 820.70(e), each manufacturer shall
establish
and maintain procedures to prevent contamination of equipment or
product by
substances that could reasonably be expected to have an adverse
effect on product
quality.
101. Pursuant to 21 C.F.R. § 820.70(g), each manufacturer shall
ensure that
all equipment used in the manufacturing process meets specified
requirement and
is appropriately designed, constructed, placed and installed to
facilitate
maintenance, adjustment, cleaning an use.
102. Pursuant to 21 C.F.R. § 820.70(h), each manufacturer shall
establish
and maintain procedures for the use and removal of manufacturing
material which
could reasonably be expected to have an adverse effect on product
quality to
ensure that it is removed or limited to an amount that does not
adversely affect the
device’s quality.
103. Pursuant to 21 C.F.R. § 820.70(i), when computers or automated
data
processing systems are used as part of production or the quality
system, the
manufacturer shall validate computer software for its intended use
according to an
established protocol.
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104. Pursuant to 21 C.F.R. § 820.72, each manufacturer shall ensure
that
all inspection, measuring and test equipment, including mechanical,
automated or
electronic inspection and test equipment, is suitable for its
intended purposes and is
capable of producing valid results. Each manufacturer shall
establish and maintain
procedures to ensure that equipment is routinely calibrated,
inspected, checked and
maintained.
105. Pursuant to 21 C.F.R. § 820.75(a), where the results of a
process
cannot be fully verified by subsequent inspection and test, the
process shall be
validated with a high degree of assurance and approved according to
established
procedures. “Process validation” means establishing by objective
evidence that a
process consistently produces a result or product meeting its
predetermined
specifications. See 21 C.F.R. § 820.3(z)(1).
106. Pursuant to 21 C.F.R. § 820.75(b), each manufacturer shall
establish
and maintain procedures for monitoring and control of process
parameters for
validated processes to ensure that the specified requirements
continue to be met.
Each manufacturer shall ensure that validated processes are
performed by qualified
individuals.
107. Pursuant to 21 C.F.R. § 820.90, each manufacturer shall
establish and
maintain procedures to control product that does not conform to
specified
requirements.
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108. Pursuant to 21 C.F.R. § 820.100, each manufacturer shall
establish
and maintain procedures for implementing corrective and preventive
action. The
procedures shall include requirements for:
(a) analyzing processes, work operations, concessions,
quality
audit reports, quality records, service records, complaints,
returned product,
and other sources of quality data to identify existing and
potential causes of
nonconforming product or other quality problems;
(b) investigating the cause of nonconformities relating to
product,
processes and the quality system;
(c) identifying the action(s) needed to correct and prevent
recurrence of nonconforming product and other quality
problems;
(d) verifying or validating the corrective and preventative action
to
ensure that such action is effective and does not adversely affect
the finished
device;
procedures needed to correct and prevent identified quality
problems;
(f) ensuring that information related to quality problems or
nonconforming product is disseminated to those directly responsible
for
assuring the quality of such product or the prevention of such
problems; and
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as well as corrective and preventative actions, for management
review.
109. Upon information and belief, the Profemur ® Total Hip System
is
adulterated pursuant to 21 U.S.C. § 351 because, among other
things, it failed to
meet established performance standards and/or the methods,
facilities or controls
used for its manufacture, packing, storage or installation are not
in conformity with
federal requirements. See 21 U.S.C. § 351.
110. Upon information and belief, the Profemur ® Total Hip System
is
misbranded because, among other things, it is dangerous to health
when used in the
manner prescribed, recommended or suggested in the labeling
thereof. See 21
U.S.C. § 352.
111. Upon information and belief, the Profemur ® Total Hip System
is
adulterated pursuant to 21 U.S.C. § 351 because Wright and/or
MicroPort failed to
establish and maintain CGMP for the Profemur ® Total Hip System,
including
components, in accordance with 21 C.F.R. § 820, et seq., as set
forth above.
112. Upon information and belief, Wright and/or MicroPort failed
to
establish and maintain CGMP with respect to the quality audits,
quality testing and
process validation for the Profemur ® Total Hip System, including
its components.
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113. As a result of Wright’s and/or MicroPort’s failure to
establish and
maintain CGMP as set forth above, the Profemur ® Total Hip System
was defective
and failed, resulting in injuries and damages to Plaintiff Elaine
Shubin.
114. If Wright and/or MicroPort had complied with the federal
requirements regarding CGMP, the Profemur ® Total Hip System would
have been
manufactured and/or designed properly such that it would not have
resulted in
injuries and damages to Plaintiff Elaine Shubin.
115. Plaintiff Elaine Shubin’s injuries and damages were both
factually and
proximately caused by the defective Profemur ® Total Hip
System.
116. Plaintiff Elaine Shubin’s injuries and damages were both
factually and
proximately caused by the unreasonably dangerous Profemur ® Total
Hip System.
117. Plaintiff Elaine Shubin further shows that she is entitled to
recover for
all noneconomic and compensatory damages allowed by law, including,
but not
limited to, pain and suffering for all pain and suffering that she
has incurred as a
result of the defective product, the follow-up surgery,
rehabilitation, and constant
pain that occurs as a result of the failure of the Device.
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(As to all Defendants)
118. Plaintiffs hereby reallege and incorporate by reference all of
the
allegations and statements contained in Paragraphs 1 through 117,
inclusive, as
though fully set forth herein.
119. At all times relevant hereto, Defendants Wright and
Microport
designed, manufactured, distributed, sold, marketed and/or promoted
the
Profemur ® Total Hip System, including the 1) Profemur
® PHA00270 Plasma Z
Stem, 2) Profemur ® PHAC1232 8° var/val CoCr Modular Femoral Neck,
3)
26000010 Ceramic Femoral Head that were implanted in Plaintiff
Elaine Shubin
on October 30, 2015.
120. At all times relevant hereto, the Profemur ® Total Hip System
was
expected to, and did, reach prescribing physicians and consumers,
including
Plaintiff Elaine Shubin and Plaintiff’s physician, without a
substantial change in
the condition in which it was sold.
121. At all times relevant hereto, Plaintiff and Plaintiff’s
healthcare
providers used the Profemur ® Total Hip System for its intended or
reasonably
foreseeable purpose.
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122. At all times relevant hereto, the Profemur ® Total Hip System
was
defective and unreasonably dangerous. Such defects included, but
were not limited
to, a tendency to (a) generate dangerous and harmful metal debris
in the patient’s
body; (b) corrode; (c) cause pain; (d) inhibit mobility; (e)
require revision surgery;
and (f) fracture.
123. Plaintiffs are informed and believe, and thereupon allege,
that the
Profemur ® Total Hip System implanted in Plaintiff, Elaine Shubin,
is defective and
unreasonably dangerous because of a manufacturing defect in the
alleged device,
as aforesaid, which contain a condition that the manufacturer did
not intend and,
as a result, failed to perform as safely as an ordinary consumer
would expect when
the product is used in a reasonably foreseeable manner and / or
because it differed
from the manufacturer’s design and specifications, or from typical
units of the
same product line.
124. As a direct, legal, proximate and producing result of the
defective
manufacture of the Profemur ® Total Hip System implanted in
Plaintiff, Elaine
Shubin, Plaintiffs sustained injuries and damages as set forth
above, for which the
said defendants are strictly liable.
125. The dangerous, unsafe and defective manufacturing of the
Profemur ®
Total Hip System implanted in Plaintiff, Elaine Shubin was a
substantial factor in
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causing Plaintiff’s injuries and damages as set forth above, for
which the said
defendants are strictly liable.
SECOND CAUSE OF ACTION
(As to All Defendants)
126. Plaintiffs repeat, reallege and hereby incorporate by
reference all of
the allegations and statements contained in Paragraphs 1 through
117 above,
inclusive, as though fully set forth herein.
127. The Profemur ® Total Hip System was defective and
unreasonably
dangerous when it left the possession of Defendants in that it
failed to provide
adequate warnings to alert the medical community and patients,
including
Plaintiffs and Plaintiff’s healthcare providers, to the dangerous
risks associated
with the Profemur ® Total Hip System when used for its intended and
reasonable
foreseeable purpose. The dangers and risks included, but were not
limited to, a
tendency to (a) generate dangerous and harmful metal debris in the
patient’s body;
(b) cause injury and pain; (c) inhibit mobility; (d) require
revision surgery; and (e)
fracture.
128. At all times relevant hereto, Plaintiffs and Plaintiff’s
healthcare
providers used the Profemur ® Total Hip System for its intended or
reasonably
foreseeable purpose.
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129. Plaintiffs and Plaintiff’s healthcare providers could not
have
discovered any defect in the Profemur ® Total Hip System through
the exercise of
due care.
130. Defendants knew or should have known, through complaint data
and
knowledge of the design’s history, by the use of generally
recognized and
prevailing scientific/ technical/ medical knowledge available at
the time of the said
product’s distribution, that a foreseeable use of the product may
be unreasonably
dangerous without adequate warnings of the danger(s) posed by
potential risks and
side effects associated with the Profemur ® Total Hip System.
Defendants knew or
should have known of the defective condition, characteristics, and
risks associated
with the Device as previously set forth herein.
131. The warnings and instructions provided with the Profemur ®
Total Hip
System by Defendants did not adequately warn of the potential risks
and side
effects of the Profemur ® Total Hip System, which risks were known
or
scientifically knowable to Defendants.
132. Defendants had a continuing duty to warn the medical community
and
public, including Plaintiff and Plaintiff’s healthcare providers,
of the potential risks
and increased failure rate associated with the Profemur ® Total Hip
System.
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133. As a direct, legal, proximate and producing result of
Defendants’
failure to warn, Plaintiff sustained the injuries and damages as
set forth above, for
which said defendants are strictly liable.
134. Defendants’ failure to adequately warn of the potential risks
and side
effects of the Profemur ® Total Hip System was a substantial factor
in causing
Plaintiff’s injuries and damages as set forth above, for which said
defendants are
strictly liable.
DESIGN)
(As to All Defendants)
135. Plaintiffs repeat, reallege and hereby incorporate by
reference all of
the allegations and statements contained in Paragraphs 1 through
117, inclusive, as
though fully set forth herein.
136. At all times relevant hereto, Defendants designed,
manufactured,
distributed, sold, marketed and/or promoted the Profemur ® Total
Hip System,
including the 1) Profemur ® PHA00270 Plasma Z Stem, 2)
Profemur
® PHAC1232
8° var/val CoCr Modular Femoral Neck, 3) 26000010 Ceramic Femoral
Head that
were implanted in Plaintiff Elaine Shubin on October 30,
2015.
137. At all times relevant hereto, the Profemur ® Total Hip System
was
expected to, and did, reach prescribing physicians and consumers,
including
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Plaintiff and Plaintiff’s physician, without a substantial change
in the condition in
which it was sold.
138. At all times relevant hereto, Plaintiff and Plaintiff’s
healthcare
providers used the Profemur ® Total Hip System for its intended or
reasonably
foreseeable purpose.
139. At all times relevant hereto, the Profemur ® Total Hip System
was
defective and unreasonably dangerous because of a design defect, as
aforesaid in
this complaint. Such defects included, but were not limited to, a
tendency to (a)
generate dangerous and harmful metal debris in the patient’s body;
(b) corrode; (c)
cause injury and pain; (d) inhibit mobility; (e) require revision
surgery; and (f)
fracture.
140. Defendants knew or should have known of the unreasonably
dangerous and serious risks associated with the design of the
Profemur ® Total Hip
System. Such risks were historically and scientifically knowable to
Defendants.
However, Defendants performed inadequate evaluation and testing of
the
Profemur ® Total Hip System design.
141. As a direct, legal, proximate and producing result of the
defective
design of the Profemur ® Total Hip System implanted in Plaintiff,
Plaintiff
sustained injuries and damages as set forth above, for which said
defendants are
strictly liable.
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142. Defendants’ dangerous design and failure to adequately test
the safety
of the Profemur ® Total Hip System was a substantial factor in
causing Plaintiff’s
injuries and damages as set forth above, for which said defendants
are strictly
liable.
(As to All Defendants)
143. Plaintiffs hereby reallege and incorporate by reference all of
the
allegations and statements contained in Paragraphs 1 through 117,
inclusive, as
though fully set forth herein.
144. At all times relevant hereto, Defendants designed,
manufactured,
distributed, sold, marketed and/or promoted the Profemur ® Total
Hip System for
implantation into customers, such as Plaintiff, Elaine Shubin by
physicians and
surgeons in the U.S.
145. At all times relevant hereto, Defendants knew or should have
known
that the history and novel design of the Profemur ® Total Hip
System necessitated
clinical trials and other pre-marketing evaluations of risk and
efficacy. Such
testing would have revealed the increased risk of failure and
complications
associated with the Profemur ® Total Hip System. A reasonable
manufacturer
under the same or similar circumstances would have conducted
additional testing
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and evaluation of the Profemur ® Total Hip System’s safety and
performance prior
to placing the Profemur ® Total Hip System into the stream of
commerce.
146. At all times relevant hereto, Defendants knew or should have
known
of the serious complications and high failure rate associated with
the Profemur ®
Total Hip System. Despite receiving hundreds of reports of serious
complications
from healthcare providers, Defendants chose (1) not to discontinue
or redesign the
Device; (2) not to perform any additional testing of the Profemur ®
Total Hip
System; (3) not investigate other potential causes of the reported
complications; (4)
suspend sales or distribution; or (5) warn physicians and patients
of the propensity
of the Profemur ® Total Hip System to generate dangerous and
harmful metal
debris in the patient’s body; cause pain; inhibit mobility;
fracture; and require
revision surgery.
147. As a direct, legal, proximate and producing result of the
Defendants’
negligent design, warning, labeling, testing, manufacturing,
marketing selling and
promoting the Profemur ® Total Hip System, Plaintiff sustained
injuries as set forth
above.
manufacturing, marketing, selling and promoting of the Profemur ®
Total Hip
System implanted in Plaintiff, Elaine Shubin was a substantial
factor in Plaintiff’s
injuries and damages as set forth above.
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FIFTH CAUSE OF ACTION
(NEGLIGENCE – FAILURE TO RECALL/RETROFIT)
(As to all Defendants)
149. Plaintiffs hereby reallege and incorporate by reference all of
the
allegations and statements contained in Paragraphs 1 through 117,
inclusive, as
though fully set forth herein.
150. At all times relevant hereto, Defendants Wright and MicroPort
knew
or should have known that the design of the Profemur ® Total Hip
System and its
warnings were dangerous or were likely to be dangerous when used in
an intended
or reasonably foreseeable manner.
151. Despite the severity and number of complaints Defendants
Wright and
MicroPort received, Defendants failed to recall, retrofit or warn
patients or
physicians about the danger of the Profemur ® Total Hip
System.
152. As a direct, legal, proximate and producing result of the
Defendants’
failure to recall the Profemur ® Total Hip System, Plaintiffs
suffered injuries and
damages as set forth above.
153. Defendants’ failure to recall the Profemur ® Total Hip
System
implanted in Plaintiff, Elaine Shubin was a substantial factor in
Plaintiff’s injuries
and damages as set forth above.
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(As to All Defendants)
154. Plaintiffs repeat, reallege and hereby incorporate by
reference all of
the allegations and statements contained in Paragraphs 1 through
117 above,
inclusive, as though fully set forth herein.
155. Defendants had a duty to truthfully represent to the
medical
community, and to Plaintiffs, Plaintiff’s healthcare providers and
the FDA, that the
Profemur ® Total Hip System had not been properly tested and not
found to be safe
and effective for its intended use.
156. Defendants knew or should have known that their
representations that
the Device was safe and effective were false and the
representations regarding the
safety and performance of the Profemur ® Total Hip System was in
fact, false.
157. Defendants failed to exercise ordinary care in determining the
truth or
falsity of their representations, and by misrepresenting the safety
and performance
of the Profemur ® Total Hip System.
158. Defendants breached their duty to present truthful
representations by
knowingly, or by want of ordinary care, misrepresenting the safety
and
performance of the Profemur ® Total Hip System.
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159. As a direct, legal, proximate and producing result of
Defendants’
concealment of material facts, Plaintiff has suffered injuries and
damages as set
forth herein.
(As to All Defendants)
160. Plaintiffs repeat, reallege and hereby incorporate by
reference all of
the allegations and statements contained in Paragraphs 1 through
117 above,
inclusive, as though fully set forth herein.
161. Wright and MicroPort, as manufacturers of the Profemur ® Total
Hip
System, were armed with superior knowledge of the latent dangers
associated with
the Device (namely corrosion, and fretting) and had a duty to
communicate these
dangers to Plaintiff and Plaintiff’s implanting surgeon.
162. Defendants had a duty to accurately and truthfully represent
to the
medical community, Plaintiff, and the public that Wright Medical
Profemur CoCr
Modular Neck, and the Wright Medical Profemur Total Hip System, had
not been
adequately tested and found to be safe and effective for the
treatment of patients
requiring a hip replacement. Instead, the Defendant knew, but
deliberately failed
to communicate this to Plaintiff or Plaintiff’s surgeon.
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163. Defendants had a duty to inform, but fraudulently concealed
from the
medical community, implanting orthopedic surgeon Dr. Ward,
Plaintiff, and the
public that the Wright Medical Profemur CoCr Modular Neck coupled
with the
Wright Medical Profemur titanium modular stem in the Wright Medical
Profemur
Total Hip System had an unreasonable and dangerous risk of
corroding, fretting,
and causing bodily injury.
164. Through the reporting of adverse events to Wright and
MicroPort, and
by reports from experts in metallurgy and biomechanics retained by
Wright and
MicroPort, Defendants knew of the risk of corrosion and subsequent
adverse tissue
reaction and resulting bodily injury present in the device
implanted in Plaintiff but
did not disclose this information. Neither Plaintiff nor
Plaintiff’s surgeon had this
information, nor could they have discovered this information
through reasonable
diligence.
165. The Defendants had a duty to communicate the increased risk
and
known failures associated with the device implanted in Plaintiff to
Plaintiff and
Plaintiff’s surgeon.
166. Plaintiff and Plaintiff’s surgeon justifiably relied upon
Defendants to
communicate known risks and failures when making both the decision
to implant
the device and the appropriate course of treatment following
Plaintiff’s index
surgery.
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167. Had Defendants accurately and truthfully represented to the
medical
community, Dr. Ward, Plaintiff, and the public the material facts
that it knew
regarding the risks of the Profemur CoCr Modular Neck coupled with
the
Profemur titanium modular stem as part of the Profemur Total Hip
System,
Plaintiff and/or Plaintiff’s healthcare provider(s) would not have
utilized
Defendants’ Profemur Total Hip System.
168. Had Defendants not fraudulently concealed the increased risk
of
corrosion, effects of corrosion, and the known failures of the
device from Plaintiff
or Plaintiff’s surgeon, Plaintiff’s injuries would have been
avoided or limited.
169. As a direct and proximate result of Defendants’
fraudulent
concealment, Plaintiff has experienced significant mental and
physical pain and
suffering, has sustained permanent injury, has undergone medical
treatment and
will likely undergo further medical treatment and procedures, has
suffered
financial or economic loss, including, but not limited to,
obligations for medical
services and expenses, and other damages.
EIGHTH CAUSE OF ACTION
(Against All Defendants)
170. Plaintiffs incorporate by reference as if fully set forth
herein the facts
alleged in paragraphs 1-117 of this Complaint.
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171. Defendants, as manufacturers and distributors of the Profemur
® Total
Hip System armed with superior knowledge regarding the latent
defects and failure
rates associated with the Device, had a duty to accurately and
truthfully represent
to the public, the medical community, Plaintiff, and Plaintiff’s
surgeon, the
material facts that it knew regarding the risks of the Profemur
CoCr Modular Neck
coupled with the Wright Medical Profemur titanium modular stem as
part of the
Profemur ®
172. Defendants made false representations of material fact to
Plaintiff
and/or her healthcare providers as to the safety and efficacy of
the Profemur CoCr
Modular Neck coupled with the Wright Medical Profemur titanium
modular neck
in the Profemur Total Hip System. Instead of disclosing the
heightened risks of
corrosion, fretting, fracture, failure, and permanent injury,
Defendnats represented:
a) that there was no indication of an increased risk of adverse
events
due to taper junction fretting and corrosion,
b) that lab testing guaranteed structural reliability and the
absence of significant micromovement and absence of
fretting corrosion;
c) that product complaint data did not indicate an increased risk
of
corrosion for Profemur CoCr Modular Necks when coupled with
Profemur titanium hip stems;
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d) that, “[u]tilized in both primary and revision applications,
the
current [Profemur modular] neck design has been successfully
employed to improve surgical outcomes with no reported
failures”;
e) that Profemur ® cobalt-chromium modular necks would result
in
less fretting than occurred with titanium modular necks;
f) that Profemur ®
Profemur ®
stems showed a total absence of corrosion in an in vivo
environment; and
g) that the Profemur Total Hip System, including its component
parts,
were safe and effective, and were safer and more effective
than
other treatments for hip replacements.
173. Defendants knew that the above representations alleged in
paragraph
172 were false, yet Defendants willfully, wantonly, and recklessly
disregarded the
inaccuracies in these representations.
174. Defendants made these false representations with the intent
of
defrauding and deceiving the medical community (including
implanting surgeon
Dr. Ward), Plaintiff, and the public, and to induce the medical
community,
Plaintiff’s implanting surgeon, Plaintiff, and the public to
utilize the Profemur
CoCr Modular Neck coupled with the Profemur titanium modular stem
as part of
the Profemur Total Hip System. Doing so constituted a callous,
reckless, willful,
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and depraved indifference to the health, safety, and welfare of
Plaintiff and the
public.
175. Plaintiff and her implanting orthopedic surgeon Dr. Ward
justifiably
relied upon Defendants’ false representations of material fact in
deciding to utilize
the Profemur Hip System, including the CoCr modular neck and
titanium modular
stem.
176. Had Plaintiff or her healthcare providers known the true facts
about
the dangers and health risks of the Profemur CoCr Modular Neck
coupled with the
Profemur titanium modular stem as components of the Profemur Total
Hip System,
they would not have utilized these products.
177. As a direct and proximate result of Defendants’ fraudulent
conduct,
Plaintiff has experienced significant mental and physical pain and
suffering, has
sustained permanent injury, has undergone medical treatment and
will likely
undergo further medical treatment and procedures, has suffered
financial or
economic loss, including, but not limited to, obligations for
medical services and
expenses, and other damages.
NINTH CAUSE OF ACTION
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178. Plaintiffs repeat, reallege and hereby incorporate by
reference all of
the allegations and statements contained in Paragraphs 1 through
177 above,
inclusive, as though fully set forth herein.
179. Plaintiff, Patrick Shubin, was and is the lawful spouse of
Plaintiff
Elaine Shubin, and as such, was and is entitled to the comfort,
enjoyment, society
and services of his spouse.
180. As a direct and proximate result of the foregoing, Plaintiff
Patrick
Shubin was deprived of the comfort and enjoyment of the services
and society of
his spouse, Elaine Shubin, and has suffered and will continue to
suffer economic
loss and has otherwise been emotionally and economically injured.
The Plaintiff,
Patrick Shubin’s injuries and damages are permanent and will
continue into the
future.
181. Plaintiff Patrick Shubin is entitled to recover damages for
his loss of
consortium in an amount to be proven at trial.
PUNITIVE DAMAGES
(As to All Defendants)
182. Plaintiffs incorporate by reference as if fully set forth
herein the facts
alleged above in this Complaint.
183. The acts of Defendants, as set forth above, was attended
by
circumstances of an evil mind, to wit: malice, or willful and
wanton conduct,
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and/or in reckless disregard of the consequences from which malice
may be
inferred and showed a total disregard for human life and human
suffering.
184. The willful and wanton conduct and evil minds of Defendants
was
conduct either purposefully committed or Defendants acted to serve
defendants’
own interests, having reason to know and consciously disregarding a
substantial
risk that its conduct might significantly injure the rights and
safety of others, or
defendant consciously pursued a course of conduct knowing that it
created a
substantial risk of significant harm to the rights and safety of
others, particularly
Elaine Shubin.
185. Defendants, when they had the opportunity to do so, repeatedly
failed
to warn or to correct a known unreasonably dangerous condition
regarding their
medical device at issue.
186. Defendants knew or should have known, in light of the
surrounding
circumstances that its conduct would naturally and probably result
in injury or
damage and continued the conduct with malice or in reckless
disregard of the
consequences, from which malice may be inferred. Accordingly,
Plaintiff is
entitled to an award of punitive damages.
///
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and/or severally, as follows:
1. For general damages for personal injuries to Plaintiffs,
according to
proof;
2. For all past, current and future medical and incidental
expenses,
according to proof;
4. For loss of consortium, according to proof;
5. For prejudgment interest, as provided by law;
6. For costs of litigation; and
7. For such other and further relief as this Court may deem just
and proper.
8. loss of earnings and any decrease in earning power or capacity
in the
future.
/s/ Steve H. Patience Steve H. Patience
SKOUSEN, GULBRANDSEN
& PATIENCE, PLC
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DEMAND FOR TRIAL BY JURY
Plaintiffs hereby demand a trial by jury to the full extent
permitted by law.
/s/ Steve H. Patience